Opdivo Receives Expanded Approval as Single Agent for Initial Therapy in Melanoma

The United States Food and Drug Administration (FDA) has approved the PD1 inhibitor, Opdivo (nivolumab), as a single agent for initial therapy of advanced melanoma. This is the sixth indication for which Opdivo has been approved in the past 12 months.

The indication for this expanded approval specifies that Opdivo can be used for treatment of metastatic melanoma without a BRAF mutation among patients who have not received prior therapy.

Melanoma is the most aggressive form of skin cancer, and often starts in the form of a mole. If detected and treated early, prior to spread, melanoma can be surgically removed. However, once melanoma has spread from its site of origin, particularly if it spreads to several distant sites in the body, it is difficult to cure with standard treatment options.

Fortunately, several new types of agents, such as Opdivo, have recently been approved, and have improved outcomes for patients with advanced melanoma. Targeted agents and immune stimulating agents have proven to be more effective than chemotherapy and radiation therapy in the treatment of this disease.

Opdivo is an agent that stimulates the patient’s immune system to help fight the cancer cells. Opdivo blocks a molecule referred to as PD-1, which is involved in suppressing the immune system’s ability to fight cancer cells. Through blocking the effects of PD-1, Opdivo restores the immune system’s ability to recognize and attack cancer cells.

Opdivo is already approved for the treatment of advanced lung and kidney cancers, as well as treatment of advanced melanoma in combination with Yervoy (ipilimumab).

The trial resulting in the expanded indication was the CheckMate -066 trial, which was a phase III trial that included over 400 patients with metastatic melanoma that could not be surgically removed. Patients had not received prior therapy and they did not have a BRAF mutation (BRAF wild type).

Patients in the trial were treated with either Opdivo or a standard treatment agent, dacarbazine.

The following results occurred at the time of an interim data analysis of the trial:

The median overall survival time had not yet been reached among patients treated with Opdivo, and was 10.8 months among patients treated with dacarbazine.

The median progression-free survival (survival without progression of cancer) was 5.1 months for patients treated with Opdivo, compared with 2.2 months for those treated with dacarbazine.

Partial or complete shrinkage of cancer (overall response rates) were achieved in 34% of patients treated with Opdivo, compared with 9% of patients treated with dacarbazine.

At the time of this data analysis, 88% of patients treated with Opdivo had ongoing anti-cancer responses.

Due to the improved outcomes among patients treated with Opdivo, those who had been treated with dacarbazine were allowed to switch to receive further treatment with Opdivo.

Trials evaluating Opdivo among patients with melanoma who have BRAF mutations are ongoing to determine its effectiveness among those patients.